Introduction of FDA's Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry
10.7501/j.issn.1674-6376.2017.01.002
- VernacularTitle:FDA的“使用组织病理学及其相关方法支持生物标志物鉴定应考虑的问题”指导原则介绍
- Author:
Huilai XIAO
- Keywords:
FDA;
nonclinical biomarker;
histopathology;
qualification;
methodology;
guideline
- From:
Drug Evaluation Research
2017;40(1):5-10
- CountryChina
- Language:Chinese
-
Abstract:
FDA issued Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry in May 2016.The guideline outlined the characteristics of nonclinical biomarker of histopathology,and explained the scientific standards for the use of histopathological methods in the nonclinical biomarker qualification.This paper introduces the main contents of the guideline,and it is expected to be helpful to the research and supervision in our country.
